Safety and Efficacy Evaluation of ArtiFix® Sealant Graft in Subjects Requiring Dural Repair Following Neurosurgery

Inclusion criteria

• Subject between the ages of 22-65 (inclusive)
• Subject is scheduled for an elective cranial or spinal surgery with a single dural defect that could not be completely repaired by primary suture. The dural defect must not exceed 6cm2 (e.g. defects of sizes 2cm X 3cm, 1cm X 5cm, can be included). The defect can be completely repaired/closed by a dural sealant graft with an overlap of 6 mm with the surrounding intact dura (only 1 graft can be implanted in each subject in a single location).
• Subject has undergone imaging (such as, CT or MRI) in the past 6 months before enrolment.
• Surgical wound is expected to be Class I/clean.
• Subject understands the study requirements and procedures, can provide written Informed Consent and is able and willing to adhere to the required follow-up visits and testing.

Exclusion criteria

• Subject has known hydrocephalus.
• Subject is unable to undergo MRI after the surgery.
• Subject's life expectancy is less than 12 months.
• Significant intraoperative hemorrhage that mandates blood transfusion.
• Subject has a local or systemic infection (e.g. urinary tract infection (UTI), active pneumonia etc.) or evidence of any surgical site infection, fever > 38.3°C, positive blood culture and/or a positive chest x-ray for acute inflammatory process.
• Subject has acquired or congenital compromised immune system and/or autoimmune disease, and/or is taking chronic immunosuppressant agents at baseline.
• Subject will require use of other forms of dural repair (i.e. dural graft or sealant).
• Subject is intended to undergo craniectomy wherein bone flap will not be returned.
• Subject with a compromised wound healing process due to past treatments (e.g. chemotherapy, radiation therapy, severe diabetes etc.) or other concurrent conditions (e.g. long-standing steroids treatment).
• Subject has been clinically diagnosed with malignancy (other than basal cell carcinoma or low-grade glioma), uncontrolled diabetes (A1C>6.5%), sepsis, and systemic collagen disease.
• Subject had chemotherapy and/or radiotherapy in the past 12 weeks before surgery or is planned to have chemotherapy or radiotherapy less than 12 weeks after surgery.
• Subject is an acute cranial trauma surgical case or had intracranial hemorrhage from any cause (hemorrhagic stroke, ruptured aneurysm etc.).
• Subject that has a concurrent disease or symptoms or conditions that would place the patient in excessive risk to the planned surgery - defined by PI.
• Subject had a previous neurosurgery in the same anatomical site.
• Subject was diagnosed with clinically significant coagulopathy as determined by the surgeon.
• Subject is participating in another clinical trial using investigational devices/drugs
• Subjects who previously participated in any investigational drug or device study within 30 days of screening
• Subject has known history of sensitivity or allergy to any component of the ArtiFix®.
• Female subjects who are breastfeeding, pregnant or interested in becoming pregnant during the duration of the study.
• Any condition or abnormality which in the opinion of the investigator may jeopardize the subject's safe participation.